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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA069533 | U.S. NIH Grant/Contract | View source | |
| OHSU-3872 | Other Identifier | OHSU IRB | |
| OHSU-CTRC-1037 | Other Identifier | OHSU OCTRI CTRC number | |
| NCI-2013-00768 | Registry Identifier | Clinical Trials Reporting Program (CTRP) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Polyunsaturated fatty acids are important for normal growth and development. One type, called omega-3 fatty acids (found in fish, fish oil, and some other foods), may affect the growth of abnormal breast cells.
PURPOSE: This randomized pilot trial is studying how well omega-3 fatty acids work in treating women with newly diagnosed ductal carcinoma in situ and/or atypical ductal hyperplasia.
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
Patients complete questionnaires at baseline, weekly during study treatment, at the completion of study treatment, and then at 30 days after completion of study treatment. These questionnaires include the Fish Oil Adverse Event Questionnaire, the Diet and Family History Questionnaire, the Changes to Diet and Medications Questionnaire, and the Post-Intervention Questionnaire.
Patients undergo blood, urine, nipple aspirate, and tissue sample collection at baseline and after completion of study treatment for translational research studies. Blood samples are analyzed for genetic markers for breast cancer risk and progression by microarray analysis and red blood cell (RBC) fatty acids. Nipple aspirate samples are analyzed for fatty acids to determine the extent to which omega-3 fatty acid supplementation alters the fatty acid profile of breast tissue. Tissue samples are analyzed for the presence of ductal carcinoma in situ and/or atypical ductal hyperplasia or invasive cancer. Leftover blood, urine, nipple aspirate, and tissue samples are stored for future research studies.
After completion of study treatment, patients are followed at 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients receive oral omega-3 fatty acid capsules 3 times daily for up to 8 weeks. |
|
| Arm II | Placebo Comparator | Patients receive oral placebo olive oil capsules 3 times daily for up to 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omega-3 fatty acid | Dietary Supplement | Oral, 3 times daily |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of omega-3 fatty acids on markers of breast cancer progression | minimum 2 weeks, maximum 8 weeks |
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DISEASE CHARACTERISTICS:
Biopsy confirmed diagnosis of any of the following:
Newly diagnosed disease
No pure invasive breast cancer on biopsy without a component of DCIS or ADH
Hormone receptor status not specified
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Jackilen Shannon, PhD | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Epic Imaging | Portland | Oregon | 97220 | United States | ||
| Knight Cancer Institute at Oregon Health and Science University |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011230 | Precancerous Conditions |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| Other |
Oral, 3 times daily |
|
| Portland |
| Oregon |
| 97239-3098 |
| United States |
| D017437 |
| Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |